BOOKER BOX, MODEL PAD 5010

K993205 · Tz Medical, Inc. · LDD · Jul 20, 2000 · Cardiovascular

Device Facts

• Record ID: K993205
• Device Name: BOOKER BOX, MODEL PAD 5010
• Applicant: Tz Medical, Inc.
• Product Code: LDD · Cardiovascular
• Decision Date: Jul 20, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Booker Box is passive connector, which allows connection to two defibrillators at a time to allow the physician to place a back up pair of electrodes. When the device is connected to two separate low energy defibrillators (using the adaptor/connectors compatible with the individual defibrillator) and disposable electrodes, energy from the defibrillator passes through the device to the external disposable electrodes. Should the physician need to the second set of electrodes are used as a back up in case the first pair configuration is unable to convert. The device also can be connected to a generic physiologic monitor recorder cable to allow unipolar recording using one of the back electrodes.

Device Story

Booker Box is a passive defibrillation cable adapter; enables simultaneous connection of two defibrillators to a single set of disposable electrodes; allows physician to maintain backup electrode pair for conversion if primary configuration fails; provides interface for generic physiologic monitor recorder cable for unipolar recording via back electrode; used in hospital and EP laboratory environments; operated by physicians; device acts as a signal/energy pass-through; facilitates clinical decision-making by ensuring immediate availability of secondary defibrillation path; benefits patient by reducing time to secondary intervention during cardiac events.

Clinical Evidence

Bench testing only. The device was tested for compatibility with various manual defibrillators including Hewlett Packard CodeMaster/7600/7800, Zoll PD1200/PD1400/M Series, Siemans 410, and PhysioControl LifePak series (LP5, LP6, LP8, LP9, LP10, LP12).

Technological Characteristics

Passive electrical connector/adapter; no active components; no energy source; dimensions/materials not specified; standalone hardware; non-sterile; no software.

Indications for Use

Indicated for use in hospital and EP laboratory settings by physicians to provide simultaneous connection to two defibrillators, enabling the placement of backup electrodes for defibrillation and connection to a physiologic monitor recorder for unipolar recording.

Regulatory Classification

Identification

Low-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. High-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.

Reference Devices

• Hewlett Packard CodeMaster
• Hewlett Packard 7600
• Hewlett Packard 7800
• Zoll PD1200
• Zoll PD1400
• Zoll M Series
• Siemans 410
• PhysioControl LifePak LP5
• PhysioControl LifePak LP6
• PhysioControl LifePak LP8
• PhysioControl LifePak LP9
• PhysioControl LifePak LP10
• PhysioControl LifePak LP12

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2000

Mr. Byron Zahler TZ Medical Inc. 15858 SW Upper Boones Ferry Road Lake Oswego, OR 97035

K993205 Re: Booker Box Defibrillation Cable Adapter, Model Pad 5001 Regulatory Class: II (two) Product Code: 74 LDD, DSA March 18, 2000 Dated: Received: April 21, 2000

Dear Mr. Zahler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Bryon Zahler

This letter will allow you to begin marketing your device as described in inzo feecer wire are area. The FDA finding of substantial your brokk, premains a legally marketed predicate device results equivalence of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation 11 you debiro opend additionally 809.10 for in vitro diagnostic (zi circ our over and add the Office of Compliance at [phone]. acviceb// produce on the promotion and advertising of your Additionally) to questions the office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on premained insibilities under the Act may be obtained from the Division of your responsibirers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Buim E. Auseyom

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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993205 510(k) Number (if known)

Device Name:

Booker Box Defibrillation Cable Adapter and Adapter/Connectors

Indications For Use:

The Booker Box is passive connector, which allows connection to two defibrillators at a time to allow the physician to place a back up pair of electrodes. When the device is connected to two separate low energy defibrillators (using the adaptor/connectors compatible with the individual defibrillator) and disposable electrodes, energy from the defibrillator passes through the device to the external disposable electrodes. Should the physician need to the second set of electrodes are used as a back up in case the first pair configuration is unable to convert. The device also can be connected to a generic physiologic monitor recorder cable to allow unipolar recording using one of the back electrodes.

- 1. Provides simultaneous connection to two defibrillators, which allows placement of a set of backup electrodes
- Provides connection to generic physiologic monitor recorder cable for unipolar recording from 2. using a back electrode.
- ડે. Used in Hospitals/EP Laboratories
- 4. Used with manual defibrillators and has been tested with the following devices:

Hewlett Packard CodeMaster Hewlett Packard 7600, 7800 Zoll PD1200, PD1400, "M" Series Siemans 410 PhysioControl LifePak LP5, LP6, LP8, LP9, LP10 and LP 12

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence Of CDRH, Office OF Device Evaluation (ODE)

E. D. Hanson

Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

Over-The-Counter Use

(Optional Format 1-2-96)

Prescription Use (Per 21 CFR 801.109)